BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis use

Summary

The FDA issued a Class II for BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, RE by CareFusion 303, Inc.. Reason: Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential dela.

Details

Product Description

BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.

Lot/Code Info: User Guides: i. BD Pyxis MedBank Cabinet User Guide v2.4 ii. BD Pyxis MedBank MedPass User Guide v1.0 iii. BD Pyxis MedBank CR Station User Guide v3.10 iv. BD Pyxis MedBank myQLink Cloud Software User Guide v1.5 v. BD Pyxis Supply Cabinet Safety Guide (for SupplyBank models) Quick Reference Guides: i. BD Pyxis MedBank CR Station QRG (part number 155018-03) ii. BD Pyxis MedBank Cabinet QRG (PN 155023-03) iii. BD Pyxis MedBank RxNow CR Station QRG (PN 155026-03) iv. BD Pyxis MedBank RxNow Solution QRG 2.0 (PN 155027-02) v. BD Pyxis MedBank MedPass QRG (PN 155022-03) vi. BD Pyxis MedBank QFill Station QRG (PN 155020-02) vii. BD Pyxis MedBank myQLink Cloud Software QRG 3.0 (PN 155021-02) REF/UDI-DI/Serial Numbers: 1119-00/10885403512704/13517006, 13523350, 13754724, 13767953, 13789575, 13801727, 13826187, 13879544, 13883357, 13884848, 13934472, 13939327, 13948724, 14032802, 14037891, 14158187, 14159916, 14168580, 14172832, 14175162, 14182716, 14202337, 14220872, 14222746, 14228149, 14228150, 14244101, 14254813, 14254816, 14254812, 14254815, 14275112, 14278095, 14317945, 14317946, 14324386, 14332058, 14347747, 14347748, 14349106, 14348708, 14348709, 14352459, 14365786, 14365785, 14374965, 14374963, 14374964, 14377079, 14378428, 14377908, 14407523, 14407524, 14420205, 14420213, 14420211, 14420207, 14420208, 14420206, 14420223, 14420222, 14420212, 14441382, 14442352, 14442359, 14442686, 14442685, 14442585, 14442586, 14445911, 14456782, 14456757, 14458260, 14458256, 14458259, 14472490, 14472338, 14472980, 14472990, 14472975, 14472981, 14472970, 14472977, 14472982, 14472971, 14472987, 14472973, 14472983, 14472972, 14472961, 14472985, 14472974, 14472989, 14472966, 14472988, 14472984, 14472964, 14472962, 14472968, 14472969, 14472967, 14472979, 14475836, 14475827, 14475839, 14475832, 14475831, 14475830, 14475828, 14475829, 14475837, 14475834, 14475835, 14532831, 14533089, 14540092, 14540091, 14540107, 14540097, 14540103, 14545019, 14549918, 14549926, 14549535, 14549924, 14549537, 14549913, 14549910, 14549934, 14549928, 14549543, 14549534, 14549542, 14549546, 14579394, 14602051, 14602043, 14602044, 14602049, 14602048, 14602050, 14618948, 14635117, 14635121, 14635120, 14635118, 14635122, 14649376, 14651893, 14656794, 14672001, 14678266, 14678259, 14678251, 14678262, 14678240, 14678261, 14678246, 14678258, 14678256, 14695735, 14695732, 14695737, 14695731, 14697048, 14697051, 14697049, 14709300, 14711347, 14711353, 14742553, 14742644, 14743937, 14743923, 14743935, 14743929, 14743932, 14743938, 14743925, 14743933, 14743934, 14743931, 14787943, 14787944, 14787922, 14787923, 14787942, 14787939, 14787919, 14787940, 14803084, 14834314, 14861749, 14861747, 14868948, 14883876, 14888627, 14888639, 14894201, 14894199, 14894200, 14894202, 14897578, 14897577, 14925753, 14942508, 14951354, 14951344, 14951377, 14951386, 14951338, 14958134, 14977993, 14990472, 14990476, 15024805, 15070091, 15086034, 15086026, 15125781, 15125782, 15125773, 15125779, 15125784, 15125777, 15125778, 15125776, 15125772, 15169037, 15176582, 15176580, 15201877, 15201878, 15206270, 15206267, 15206269, 15210095, 15210091, 15210094, 15210089, 15210104, 15210088, 15210090, 15210106, 15213239, 15216160, 15223570, 15223560, 15223568, 15223571, 15229115, 15229108, 15229107, 15229119, 15229118, 15236627, 15240793, 15242603, 15242599, 15242596, 15242602, 15242605, 15242606, 15245775, 15245774, 15245776, 15245777, 15253442, 15254778, 15254776, 15254774, 15254772, 15254775, 15268840, 15268836, 15268851, 15268838, 15268856, 15268850, 15268835, 15279442, 15279443, 15279444, 15279455, 15279458, 15279454, 15290675, 15294474, 15299940, 15308354, 15317099, 15317097, 15317100, 15317104, 15317101, 15317102, 15322148, 15322145, 15340242, 15340240, 15340245, 15340241, 15340239, 15340251, 15340243, 15340238, 15356973, 15356977, 15361554, 15361559, 15361555, 15361553, 15369939, 15389013, 15389673, 15391644, 15391311, 15392443, 15392451, 15392447, 15392449, 15393558, 15396726, 15416741, 15460705, 15460996, 15460706, 15460997, 15460707, 15461858, 15463097, 15463095, 15463096, 15464898, 15470033, 15470035, 15470034, 15471183, 15473693, 15473692, 15474596, 15474551, 15492248, 15492211, 15498908, 15500854, 15509359, 15509361, 15509364, 15509365, 15509366, 15513835, 15513825, 15513834, 15513826, 15513833, 15513830, 15513831, 15517161, 15519704, 15519700, 15521199, 15521203, 15521200, 15521201, 15554707, 15557611, 15561697, 15564895, 15564897, 15564894, 15564893, 15564896, 15583141, 15584199, 15613096, 15614585, 15622613, 15622611, 15622635, 15638496, 15638495, 15643124, 15643125, 15643128, 15647364, 15647367, 15652143, 15652147, 15652138, 15652145, 15661682, 15661681, 15679247, 15679269, 15679254, 15679243, 15679263, 15679237, 15679245, 15682324, 15691543, 15736824, 15736832, 15736823, 15748541, 15748544, 15748543, 15779891, 15788872, 15788870, 15788868, 15803799, 15835058, 15835059, 15853794, 15854592, 15854989, 15855085, 15855653, 15855651, 15855650, 15855649, 15855652, 15906182, 15923716, 15924566, 15924567, 15929989, 15931343, 15933057, 15933056, 15937957, 15940593, 15940620, 15942158, 15942157, 15942159, 15956999, 15957002, 16030464, 16039729, 16045065, 16053361, 16063826, 16066740, 16081624, 16084502, 16089562, 16089561, 16089912, 16090406, 16090401, 16090325, 16090399, 16090308, 16090687, 16091227, 16091885, 16112808, 16112853; 1145-00/10885403517167/15383483, 15389562, 15422138, 15422139, 15442792, 15500700, 15500693, 15504839, 15504841, 15518256, 15518261, 15550844, 15550852, 15550857, 15569626, 15598106, 15600761, 15639702, 15654701, 15654698, 15662824, 15662821, 15684799, 15684812, 15715761, 15715760, 15715748, 15715742, 15723806, 15723817 15728652, 15728657, 15747087, 15761382, 15770179, 15770181, 15770187, 15770221, 15770215, 15770217, 15770207, 15770172, 15806707, 15806718, 15867348, 15928765, 15930653, 15932837, 15935612, 15941687, 15957628, 15958445, 15958444, 15962003, 15962008, 15962006, 15962002, 15962016, 15961996, 15961979, 15961986, 15962018, 15967374, 15967375, 15967376, 15978031, 16006031, 16295928, 16295929, 16295930, 16295931, 16296379, 16296380, 16296360, 16297667, 16297668, 16297669, 16297671, 16300643, 16300642, 16300639, 16300641, 16300640, 16301023, 16301024, 16301018, 16301021, 16301020, 16301015, 16301016, 16302339, 16302328, 16302327, 16302337, 16302343, 16302338, 16302331, 16302332, 16302333, 16302342, 16302340, 16302329, 16302330, 16303465, 16303469, 16303463, 16303466, 16303468, 16303467, 16305129, 16305136, 16305134, 16305130, 16305133, 16306411, 16306401, 16306402, 16306413, 16306408, 16306419, 16306403, 16306397, 16306399, 16306404, 16306393, 16306395, 16308990, 16308989, 16308977, 16308973, 16308987, 16308979, 16308993, 16308998, 16308971, 16308992, 16308975, 16308991, 16310008, 16310002, 16310003, 16310011, 16310001, 16310010, 16310004, 16310006, 16310013, 16310012, 16310007, 16310005, 16313001, 16313000, 16312997, 16314266, 16314269, 16314272, 16314270, 16314264, 16314265, 16314271, 16314268, 16314267, 16314273, 16316468, 16316472, 16316474, 16316478, 16316476, 16316470, 16317878, 16320189, 16320186, 16320192, 16320188, 16320193, 16320184, 16320194, 16320187, 16320190, 16321788, 16321799, 16321815, 16321806, 16321804, 16321809, 16321812, 16321814, 16321794, 16321792, 16322984, 16322983, 16322982, 16324943, 16324939, 16324942, 16324945, 16324946, 16324940, 16324947, 16324950, 16324949, 16327197, 16327189, 16327194, 16327209, 16327210, 16327190, 16327200, 16327205, 16327193, 16327196, 16327188, 16327202, 16327195, 16327191, 16327187, 16327192, 16327183, 16327208, 16328663, 16328664, 16328776, 16328661, 16328667, 16328781, 16328778, 16328777, 16328668, 16328662, 16328779, 16328780, 16328672, 16328783, 16330466, 16330461, 16330456, 16330464, 16330459, 16335375, 16335374, 16337040, 16337050, 16337034, 16337048, 16337035, 16337036, 16337039, 16337038, 16337037, 16340968, 16340991, 16340990, 16340967, 16340993, 16340994, 16340995, 16340992, 16344721, 16346261, 16346262, 16346259, 16346260, 16349691, 16354505, 16354507, 16354503, 16358680, 16361332, 16362405, 16362406, 16362407, 16362404, 16365321, 16365319, 16365318, 16365317, 16366692, 16366693, 16366691, 16372443, 16372445, 16373059, 16373055, 16372452, 16372446, 16372444, 16374659, 16374257, 16374087, 16374261, 16374258, 16374657, 16374260, 16374259, 16374090, 16381296, 16381293, 16381297, 16381284, 16381291, 16381292, 16381298, 16381282, 16381294, 16381295, 16388214, 16388837, 16388244, 16388835, 16388252, 16388834, 16388840, 16388838, 16388249, 16388845, 16388839, 16388844, 16388836, 16388843, 16390540, 16390541, 16390534, 16389774, 16390530, 16390531, 16389914, 16390532, 16390533, 16394968, 16394967, 16394970, 16394976, 16394974, 16394969, 16394977, 16394971, 16397530, 16397529, 16396551, 16397531, 16396552, 16396553, 16396550, 16398856, 16398277, 16398853, 16398851, 16398854, 16398278, 16398861, 16398862, 16398850, 16398279, 16404356, 16403805, 16404334, 16403809, 16404332, 16404330, 16403807, 16403808, 16403810, 16404354, 16403806, 16404350, 16406056, 16406057, 16405232, 16407123, 16407698, 16407705, 16407703, 16407700, 16407598, 16407702, 16409385, 16409381, 16409386, 16409388, 16409382, 16409383, 16409387, 16411894, 16411893, 16412168, 16412170, 16412169, 16412167, 16412171, 16412172, 16412173, 16412114, 16413365, 16413370, 16413361, 16413362, 16413363, 16413366, 16413359, 16413369, 16413367, 16413371, 16413364, 16413368, 16413360, 16413372, 16413726, 16413723, 16413721, 16413722, 16413725, 16413701, 16413724, 16414137, 16414138, 16414136, 16414139, 16414133, 16414134, 16414135, 16415214, 16415210, 16415212, 16415211, 16415209, 16415213, 16416190, 16416191, 16416189, 16417406, 16422217, 16422218, 16422219, 16423051, 16424562, 16427306, 16427307, 16430664, 16434523, 16434526, 16437155, 16455468, 16468103, 16468104, 16468101, 16472326, 16478387, 16487428, 16487425, 16491408, 16491396, 16490496, 16491407, 16491392, 16491388, 16491409, 16491384, 16491400, 16491403, 16503897, 16502516, 16503896, 16502330, 16502329, 16506554, 16516780, 16516782, 16516768, 16516771, 16516779, 16521603, 16521274, 16525037, 16528924, 16528929, 16528927, 16528926, 16531501, 16531503, 16531506, 16531500, 16534640, 16534642, 16538799, 16538803, 16538800, 16538797, 16543333, 16543118, 16543329, 16543110, 16543106, 16543327, 16543331, 16543115, 16543121, 16543112, 16543103, 16543134, 16543137, 16543139, 16550107, 16550109, 16550070, 16550059, 16550092, 16550104, 16550054, 16550091, 16550105, 16550111, 16550089, 16550097, 16550094, 16550065, 16550068, 16550113, 16550101, 16550096, 16550051, 16550057, 16550099, 16550073, 16550061, 16558929, 16558933, 16558936, 16562377, 16565583, 16565598, 16565590, 16565593, 16566155, 16566151, 16565842, 16569428, 16570197, 16574504, 16574497, 16575830, 16575876, 16575873, 16574501, 16575886, 16574502, 16574539, 16575874, 16575868, 16575878, 16574505, 16575881, 16575875, 16574483, 16574465, 16575883, 16579156, 16579074, 16577899, 16577882, 16577898, 16577897, 16579071, 16579138, 16579150, 16577892, 16577888, 16577890, 16577889, 16579151, 16579135, 16579140, 16579145, 16579142, 16579152, 16579079, 16579147, 16577887, 16577900, 16577886, 16577895, 16579076, 16587457, 16587545, 16587543, 16587531, 16587522, 16587454, 16587460, 16587458, 16587465, 16587474, 16587468, 16587470, 16587473, 16587467, 16587471, 16587469, 16587462, 16587500, 16587510, 16586539, 16596355, 16596358, 16596302, 16596298, 16596370, 16596312, 16596353, 16596369, 16596372, 16596367, 16596364, 16596361, 16596352, 16596371, 16598754, 16619506, 16619487, 16619490, 16619492, 16619491, 16620691, 16620696, 16620694, 16620693, 16620695, 16620692, 16620697, 16623549, 16623551, 16623577, 16623557, 16623570, 16623573, 16623554, 16623576, 16623580, 16623591, 16623574, 16623560, 16623565, 16623590, 16623558, 16623586, 16623561, 16623567, 16623581, 16623563, 16626146, 16628039, 16642586, 16643140, 16647712, 16647715, 16647718, 16647720, 16647710, 16661317, 16661312, 16661053, 16661054, 16661052, 16661068, 16661066, 16661055, 16661059, 16661069, 16661306, 16661067, 16661057, 16661070, 16661065, 16661071, 16661072, 16661174, 16661056, 16661058, 16675865, 16675806, 16675871, 16675809, 16675810, 16675812, 16675815, 16675816, 16687013, 16686999, 16687007, 16687012, 16687009, 16687034, 16687030, 16687031, 16691053, 16691047, 16691046, 16691048, 16691050, 16714005, 16714012, 16714011, 16714006, 16714004, 16714003, 16714010, 16714002, 16714009, 16714016, 16717428, 16719593, 16719596, 16719595, 16719599, 16719598, 16721479, 16721475, 16727771, 16744366, 16744353, 16744355, 16744359, 16744361, 16744364, 16744368, 16744374, 16744378, 16744380, 16744383, 16744386, 16748233, 16748232, 16747878, 16748231, 16748236, 16748234, 16748235, 16747877, 16757818, 16757991, 16757816, 16765178, 16765179, 16765206, 16765205, 16765176, 16778164, 16777301, 16778147, 16778149, 16777334, 16778155, 16778158, 16777447, 16778005, 16778151, 16777434, 16777438, 16790043, 16790041, 16790065, 16790067, 16790066, 16790069, 16790072, 16790052, 16790091, 16790085, 16809175, 16809173, 16809171, 16809172, 16809154, 16809157, 16809153, 16809156, 16809177, 16814469, 16819236, 16828263, 16828262, 16827800, 16827801, 16827775, 16827776, 16827790, 16827805, 16828271, 16827774, 16827779, 16828269, 16828270, 16835645, 16835627, 16835639, 16835635, 16839254, 16839260, 16845151, 16845154, 16859280, 16859279, 16859282, 16859283, 16859278, 16862767, 16876539, 16876544, 16876537, 16876538, 16876541, 16876542, 16876543, 16876530, 16876553, 16876642, 16876531, 16879334, 16885231, 16913496, 16913502, 16941839, 16941859, 16941863, 16941971, 16941977, 16941980, 16941986, 16941992, 16941996, 16941998, 16941856, 16941860, 16941862, 16941870, 16941872, 16941945, 16941952, 16941956, 16941966, 16941968, 16941970, 16941973, 16941976, 16941978, 16941982, 16941989, 16941874, 16941876, 16941879, 16941937, 16941939, 16995447, 16995453, 16995395, 16995390, 16995384, 16995388, 16995469, 17001324, 17001326, 17001323, 16998700, 17001320, 17001321, 17001338, 17001341, 17001339, 17001340, 17012284, 17012244, 17012243, 17012245, 17012246, 17012247, 17012248, 17012241, 17012239, 17012287, 17012240, 17012236, 17012237, 17012265, 17012293, 17012294, 17023498, 17024246, 17026710, 17026713, 17026714, 17026718, 17027998, 17032607, 17032609, 17037413, 17037415, 17037428, 17037430, 17037310, 17037321, 17037331, 17037333, 17037397, 17037405, 17037409, 17037410, 17037411, 17037416, 17037422, 17048247, 17048248, 17048250, 17048251, 17048253, 17048263, 17048264, 17048266, 17048274, 17055666, 17055667, 17055658, 17055659, 17055660, 17055663, 17055665, 17055649, 17055654, 17055656, 17064233, 17064235, 17064240, 17068658, 17070601, 17070609, 17070614, 17070617, 17070618, 17070593, 17070597, 17070598, 17070607, 17070611, 17070604, 17070619, 17070620, 17070621, 17070622, 17070631, 17070632, 17070633, 17070634, 17070635, 17070642, 17070446, 17070445, 17070444, 17070640, 17070447, 17070443, 17070441, 17076841, 17076874, 17076930, 17076932, 17076933, 17076887, 17076885, 17076926, 17076897, 17076924, 17076922, 17076878, 17076892, 17077313, 17076865, 17076872, 17076857, 17076859, 17076890, 17076894, 17076900, 17076928, 17076882, 17076844, 17076808, 17076836, 17076833, 17076849, 17075823, 17076807, 17085484, 17088226, 17088227, 17088230, 17088229, 17088234, 17088231, 17088232, 17088237, 17088238, 17103254, 17103241, 17103244, 17103247, 17103252, 17103263, 17103267, 17103242, 17103289, 17103281, 17102985, 17103287, 17103257, 17113877, 17113880, 17113844, 17113878, 17113398, 17113399, 17113400, 17113856, 17113857, 17113858, 17113860, 17113863, 17113866, 17113868, 17113391, 17113395, 17113397, 17118818, 17118826, 17118817, 17118819, 17118820, 17118827, 17118816, 17123009, 17123011, 17123015, 17123012, 17123055, 17128730, 17128735, 17128736, 17140940, 17140943, 17140945, 17140949, 17140952, 17140970, 17140971; 139088-01/43847406, 43847407, 44684409, 44684415, 44684412, 44688684, 44694783, 44740218, 44775526

Quantity Affected: 1521

Reason for Recall

Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-01-10

Company